The Subcommittee on Conservation, Energy, and Forestry held its final hearing today on the 2012 Farm Bill. Testimony focused on Formulation of the 2012 Farm Bill: Energy and Forestry Programs. BIO’s President & CEO Jim Greenwood joined the panel testifying about Farm Bill energy programs along with Ryan Stroschein, Agriculture Energy Coalition; Steve Reinford, Reinford Farms Inc.; Jerry Taylor, MFA Oil; and Gary Haer, National Biodiesel Board.

“Farm Bill energy programs are working and BIO member companies are beginning to put steel in the ground,” Greenwood said. He highlighted several companies that have biorefineries today as a result of these programs, including INEOS Bio New Planet Energy in Florida, Myriant in Louisiana, and ZeaChem in Oregon.

Greenwood urged the committee to reauthorize the Farm Bill energy programs, such as the Biorefinery Assistance Program, BCAP, and the Biobased Markets Program, with meaningful mandatory funding to allow them to continue to spur America’s energy and agricultural future.

Farm Bill energy programs have had a tremendous positive impact in revitalizing rural America, helping new agricultural markets emerge, and reducing the need for direct payments to farmers. These programs have unlocked private capital for construction of the nation’s first cellulosic and advanced biofuel biorefineries; put more than 150,000 acres of underutilized farmland in more than 150 counties into production raising next generation energy crops; and led to an explosion of renewable chemicals innovation, demonstration and early commercialization here in the United States. For a modest federal investment a high rate of return has been achieved in terms of viable projects funded and operating.

Renewable energy is cleaner, safer and healthier. We cannot afford to wait to fund renewable energy projects that can create permanent jobs in rural America. Now is not the time to abandon these forward-looking, high return programs.

Other panelists echoed Greenwood’s sentiments in their testimony that energy program funding is necessary to continue bringing these innovative technologies to market and are a vital component to the bipartisan all of the above energy strategy of the United States. Stroschein of the Agriculture Energy Coalition warned that not funding these programs leaves other countries poised to leap ahead in clean energy technologies undermining our national and economic security.

Greenwood added that these energy programs allow American farmers and foresters to play the role they can – and must – play in producing domestic energy and therefore improving national security and rural economic prosperity.

Celiac disease is one of the most common autoimmune conditions in the U.S. but frequently goes undiagnosed.  The cause is currently unknown and it can develop at any point in life.  People who have a relative with the disease are more likely to develop it, and women are more likely than men to have it.

When people with celiac disease eat food with gluten, their immune system reacts by damaging areas of the lining of their intestines. Symptoms can vary from patient to patient but can include abdominal pain, bloating, gas, indigestion, nausea, vomiting, decreased appetite and unexplained weight loss.  This variance in symptoms is one reason celiac disease can be difficult to diagnose.

There is currently no cure for celiac disease but it can be managed with a gluten-free diet.  Wheat, barley, and rye contain gluten but other grains (including quinoa, buckwheat, millet and amaranth) do not.

According to the International Service for the Acquisition of Agri-Biotech Applications, researchers are currently seeking to develop wheat that would be safe for celiac disease patients to consume.

Dr. Peter H.R. Green

Dr. Peter H.R. Green, Director of The Celiac Disease Center at Columbia University and Professor of Clinical Medicine at the College of Physicians and Surgeons at Columbia University in New York City, spoke with BIOtechNow to raise awareness of what celiac disease is, how it is diagnosed and the treatment options.

As a result of these forces, we're seeing pharma breaking down many of the old barriers that had been established to guard the research castle. Pharma scientists are being reorganized into smaller groups and redeployed to get closer to the top development hubs, while companies restructure internal research divisions from soup to nuts. And biotechs have been springing up in the richest fields aiming to advance disruptive ideas, increasingly looking to partner up with pharma at a very early stage of development. 

Getting to mid-stage proof of concept data on a careful budget is now one of the most demanding mandates in the industry. And I'll be moderating a breakfast panel on June 19 with a group of experts who will explore just how this trend is reshaping the way drugs are discovered and developed. 

Joining us at the Westin Waterfront in Boston will be Jason Gardner, head of the Center of Excellence in External Drug Discovery for GlaxoSmithKline; "Mene" Pangalos, executive vice president, innovative medicine, at AstraZeneca; Jim Burns, head of the Sanofi Boston R&D hub; biotech veteran Jill Milne, who helped found the virtual biotech company Catabasis Pharmaceuticals; and Bernard Munos, the founder of the InnoThink Center for Research in Biomedical Innovation, one of the most influential industry voices calling for change in R&D.

We're hosting this discussion as an affiliated event to the big BIO annual confab. So if you're already in Boston, or planning to attend BIO, I hope to see you there. It's one of the most important discussions now under way in biopharma. You won't want to miss it. And if there's something you'd like to tell me about, be sure to come by after the breakfast. I'm staying until the last guest leaves. Register for the breakfast here. -- John Carroll, Editor-in-Chief. Follow me on Twitter and LinkedIn.

Yet the site is far from even approaching the biotech largesse of Boston/Cambridge. This week Gov. Deval Patrick and officials from the University of Massachusetts, which will run the new facility, stood on the muddy construction site and talked up the future prospects of the project, The Herald News reported. With grand projections to employ 8,000 people at a life sciences park planned for the area, the biotech facility is expected to house a modest 10 UMass employees when it opens next year.

Patrick championed the growth of the life sciences industry in the Bay State with a $1 billion plan to stimulate biotech activity that was passed early in his first term, yet lawmakers from around the state demanded that the money flow to areas outside of the state's industry core in the Boston area. The state's Life Sciences Center, which administers the stimulus money, granted about half of the funding for the project with UMass and other sources cobbled together the rest, according to the Herald.

Fall River has a history as a hub of manufacturing in the Bay State, and officials hope that the production of life sciences products in the city will bring new jobs. The new facility will serve as a test site for producing biotech products and house startups involved in life sciences.

- here's the Herald article

Related Articles:
Biotech building boom restricted to top 'micro' hot spots
Biotech clusters defend their turf as challenges mount
Boston biotech hub spawns more jobs, grabs big share of VC bucks

"I'd say the HDL hypothesis is on the ropes right now," said outside observer Dr. James A. de Lemos, a professor at the University of Texas Southwestern Medical Center, as quoted by The New York Times.

The HDL mechanism took a recent blow last week when Swiss drug giant Roche ($RHHBY) announced that it was nixing development of its contender designed to raise good cholesterol to thwart heart disease because of absent efficacy, following previous failures at Pfizer ($PFE) and Abbott ($ABT). Informed of the new genetic study revealed this week in The Lancet, Merck and Lilly representatives told the Times that the companies were both undeterred and continuing with their massive CETP programs. Yet the findings have dampened expectations for the drugs.

"This will have a sobering effect, it would have to," said John LaMattina, a senior partner at PureTech Ventures and former Pfizer R&D chief, as quoted by Bloomberg. "HDL has always been a controversial area. You have a question that you have to be willing to commit over a billion dollars in order to get the answer, and that is a very daunting commitment."

With billions of dollars in development costs and potential revenues on the line, expect scientists inside and outside of biopharma companies to take heed of the findings and dig deeper into the role of HDL in heart disease. As the Times notes, mouse studies showed that HDL carried cholesterol out of the arteries. But scientists will now look into whether HDL is an indicator or driver of reduced heart-attack risk.

- read the NYT's article
- and Bloomberg's report

Related Articles:
Roche abandons potential blockbuster cholesterol drug
Developers spotlight huge potential of new class of cholesterol drugs
Lilly heralds PhII success for mega-blockbuster cholesterol drug contender

Kleiner Perkins Caulfield & Byers has closed the books on a new $525 million fund. And a chunk of that treasure is earmarked for early-stage life science companies promising to satisfy Kleiner Perkins' trademark appetite for disruptive new technologies.

"Portfolio companies in KPCB 15 will benefit from the firm's holistic approach to company building that we pioneered more than a decade ago," said Ted Schlein, partner at KPCB, in a statement. "We will identify promising early-stage companies in our areas of focus and bring value-added resources in key areas to help early-stage companies grow and succeed. This includes applying our considerable industry, operational and financial expertise and network of relationships to help entrepreneurs build lasting enterprises."

Among the group of partners with a key to the cash box is Beth Seidenberg, the former chief medical officer at Amgen ($AMGN) who has been handling the fund's investments in Tesaro, Epizyme, iPierian and Auxogyn, among others. KPCB has also invested in Foundation Medicine and Celladon. 

Seidenberg's interest in biotech goes well beyond the boardroom. She's been one of the leading forces at the Medical Innovation and Competitiveness Coalition, which joined up with the National Venture Capital Association to apply pressure on the FDA to change. The lobbying effort has helped inspire new legislation aimed at speeding drug approvals while putting the FDA on the defensive about its regulatory track record.

"The major problem is the lack of predictability, which leads to delayed timelines," Seidenberg told The Wall Street Journal last fall. "Entrepreneurs are smart people, and they want to get their products to patients. And because of the lack of transparency, and the lack of consistency (at FDA), they are moving to Europe, setting up their organizations and creating jobs overseas." 

- here's the press release

Related Articles:
Google, Kleiner Perkins boost sequencing startup's A round to $33.5M
Foundation Medicine raises $33.5M in expanded Series A

Canadian authorities have stamped an approval on Osiris' Prochymal, a drug made with mesenchymal stem cells from adult donors, to treat certain children with potentially lethal graft versus host disease (GvHD), the company announced Thursday. The stem-cell drug has approval only for children whose disease can't be controlled with steroids, which doctors typically use to ward off the immune attacks from the ailment. Osiris will have to conduct post-approval clinical studies as a condition of the market nod for the treatment in Canada.

"This is the first regulatory approval of a stem-cell drug--where the active ingredient of the drug is a stem cell--in the world," Osiris CEO Randal Mills said, as quoted by Bloomberg. "It's a huge deal for us and a huge deal for the entire field of stem-cell therapy."

The approval provides a welcome turnaround for Osiris, which has been riddled by a string of recent setbacks. In February French drug giant Sanofi ($SNY) ditched work on Prochymal, for which the company had rights the sell outside of North America, The New York Times reported. The FDA last year rejected Osiris' bid for approval of the therapy as a treatment for GvHD, requesting more data from the developer. And the stem-cell field as a whole suffered a blow when Geron ($GERN) revealed last year that the biotech was shutting down its stem-cell programs.

Yet Osiris hasn't hit the jackpot. After spending years developing Prochymal, the company is expected to make only modest revenues from the drug for children in Canada with GvHD. Piper Jaffray analyst Edward Tenthoff projected sales of the drug to hit $16.7 million next year, Bloomberg reported. In the meantime, Osiris aims to build on this approval with another regulatory submission in the U.S. this year and has been developing the drug for other uses such as Type 1 diabetes, Crohn's disease and for patients who have suffered heart attacks.

- here's the release
- get more from the NYT article
- check out Bloomberg's report

Related Articles:
Osiris stem cell treatment can't beat placebo in diabetes study
Stem cell research progress proliferating in 2012

Irvine, CA-based Allergan aims to build a 93,000-square-foot R&D expansion in Bridgewater, NJ, with the help of $14.9 million grant awarded last year from the state's economic-development authority, the New Jersey Star-Ledger reports. The timing and exact number of new jobs planned at the Allergan facility was unclear, though the newspaper wrote that the facility was expected to bring 400 jobs to the state.

FierceBiotech left a message for Allergan to seek clarification, as it wasn't clear how many of the 400 new jobs would be for R&D positions and other roles at the new facilities.

Allergan--which is known for Botox and products such as the Lap-Band obesity device--hit $1.6 billion in Botox sales last year and aims to expand use of the product in new indications such as a blockbuster use treating arthritis. The company, which about 10,000 employees in 100 countries, has many developmental projects in the pipeline in the fields of neurology, ophthalmology, dermatology, urology and devices.

"As a multispecialty health care company, a critical component to our business is the scientific innovation derived from the work of our R&D facilities throughout the United States," Allergan Spokeswoman Cathy Taylor said, as quoted by the Star-Ledger. "The expansion of our facility in New Jersey will enable us to further enhance our product pipeline and advance our pursuit of novel medical therapies for patients."

- see the Star-Ledger's article

Related Articles:
NJ wins heated competition for Allergan's new R&D facility
Allergan asks FDA for lucrative new Botox indication
Allergan to plow $350M into bigger Botox capacity